A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT ID: NCT07072169

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-26

Study Completion Date

2027-05-31

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of mRNA encoding CD19/CD3 T cell engager (ABO2203) in adult patients with relapsed or refractory CD19-positive B-NHL, This study included dose escalation and dose expansion parts.

Detailed Description

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Conditions

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B-cell Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A study of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with relapsed or refractory B

ABO2203

Group Type EXPERIMENTAL

ABO2203 Injection

Intervention Type DRUG

SC or IV

Interventions

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ABO2203 Injection

SC or IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥18 years and ≤75 years of age at time of informed consent
* Participants with histologically and/or cytologically confirmed relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma
* With at least one of evaluable/measurable target lesions per Lugano 2014 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
* Life expectancy of ≥3 months
* Sufficient organ function

Exclusion Criteria

* Central nervous system lymphoma
* Previously undergone allogeneic hematopoietic stem cell transplantation or other organ transplants
* Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or carcinoma in situ of the cervix
* History of active autoimmune diseases
* History of interstitial lung disease, tuberculosis, or other diseases that affect pulmonary function in the past or currently
* Uncontrolled disease, including but not limited to uncontrolled diabetes, hypertension, active infections, active peptic ulcers, thromboembolic disease requiring anticoagulation, etc.
* Severe cardiovascular diseases
* History of severe allergies to protein-based drugs or any component of the study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei li Zhao

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pei miao Zhang

Role: CONTACT

010-57593072

Facility Contacts

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Pei miao Zhang

Role: primary

010-57593072

Other Identifiers

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ABO2203-003

Identifier Type: -

Identifier Source: org_study_id

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